FDA.reportPublic FDA data

Exel Vaculet Blood Collection Set

Primary DI
20020221267642
Brand
Exel Vaculet Blood Collection Set
Company
Exel International
Model
26764
Catalog number
26764
Device description
Blood Collection Set, 21G X 3/4, 12" tubing
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20020221267642PackageGS14In Commercial Distribution
10020221267645PrimaryGS10
00020221267648Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2002022126764220020221267642
1002022126764510020221267645
00020221267648000202212676480202212676480020221267648

GMDN Terms#

Term, Definition table
TermDefinition
Venous butterfly needle/setAn invasive device/collection of devices which includes a sharp and rigid needle intended to puncture a vein to collect blood and/or for transient (<24 hours) administration of intravenous (IV) fluids. The needle includes wings for fixation/placement and may include tubing/connectors; it is not, and does not include, a peripheral catheter. The device may be referred to as a butterfly needle or scalp vein needle. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
180572216
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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20020221260407EXEL Syringes26040260402016-09-20
20020221260421EXEL Syringes26042260422016-09-20
20020221260438EXEL Syringes26043260432016-09-20
20020221260445EXEL Syringes26044260442016-09-20
20020221260490EXEL Syringes26049260492016-09-20
20020221260506EXEL Syringes26050260502016-09-20
20020221261008EXEL Syringes26100261002016-09-20
20020221261015EXEL Syringes26101261012016-09-20
20020221261022EXEL Syringes26102261022016-09-20
20020221261039EXEL Syringes26103261032016-09-20
20020221261046EXEL Syringes26104261042016-09-20
20020221261053EXEL Syringes26105261052016-09-20
20020221261077EXEL Syringes26107261072016-09-20
20020221261084EXEL Syringes26108261082016-09-20
20020221261091EXEL Syringes26109261092016-09-20
20020221261107EXEL Syringes26110261102016-09-20
20020221261114EXEL Syringes26111261112016-09-20
20020221261121EXEL Syringes26112261122016-09-20
20020221261152EXEL Syringes26115261152016-09-20
20020221261169EXEL Syringes26116261162016-09-20

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